Airway ManagementPhase 4NCT02339519
A Comparison of Supraglottic Airway Devices
A Phase 4 study testing LMA CLASSIC, LMA FASTRACH and LMA SUPREME in people with Airway Management, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic complications. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- LMA CLASSIC, LMA FASTRACH and LMA SUPREME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normotensive patients with mouth aperture > 3 cm,
- thyromental distance > 6 cm,
- sternomental distance > 12.5 cm,
- body mass index < 35 kg m-2 were included in the study.
Who cannot join
- patients with ASA III-IV,
- those with a history of gastroesophageal reflux,
- pregnancy,
- cardiovascular and central nerve system disease,
- those with difficulty in cooperation,
- those undergoing intracranial, intraabdominal and Ear-nose-throat surgeries were excluded from study.
- None of the methods changed after commencement of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Umraniye Education and Research Hospital
Istanbul, Turkey
About this study
Official title: A Comparison of Supraglottic Airway Devices; Lma Classic, Lma Fastrach and Lma Supreme; a Prospective, Randomized, Clinical Trial of Efficacy, Safety and Complications
This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic complications.
Read the detailed description
As a result of studies regarding the provision of an airway which is less invasive than intubation but safer than mask to maintain patency of airway after anesthesia induction in brief surgical interventions, supraglottic airway devices have been introduced into practice. They are inserted to glottic entry via the oral route and can be used in emergent conditions where tracheal intubation and mask anesthesia are challenging.
Classic LMA was first introduced by Archie Brain, MD in 1988, and consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
Fastrach LMA ( LMA Fastrach: LMA North America. Inc. San Diego. CA) was first introduced in 1997 and has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
Supreme LMA, first introduced in April, 2007, is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner because of the advanced cuff and airway tube. The integrated gastric canal facilitates gastric aspiration.
Supraglottic airway devices seem to have advantages over each other in different aspects due to their distinct features. In literature, there are studies comparing various LMA types for different features. However, to best of our knowledge, there is no study comparing these 3 types of LMA regarding these parameter. This is the main point of difference of our study.
- Conditions
- Airway Management
- Being tested
- LMA CLASSIC, LMA FASTRACH, LMA SUPREME
- Keywords
- Laryngeal Masks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA CLASSICDevice
Classic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
LMA FASTRACHDevice
Fastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
LMA SUPREMEDevice
Supreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner.
| Study group | Role | What they receive |
|---|---|---|
| group LMA supreme | Active comparator | Patients who received Laryngeal Mask Airway; LMA supreme Receives: Device: LMA SUPREME |
| group LMA classic | Active comparator | Patients who received Laryngeal Mask Airway; LMA classic Receives: Device: LMA CLASSIC |
| group Fastrach | Active comparator | Patients who received Laryngeal Mask Airway; LMA fastrach Receives: Device: LMA FASTRACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of insertion will be rated using a 4-point scale (4: success at the first attempt without tactile resistance; 3: success at the first attempt with tactile resistance; 2: success at the second attempt; 1: failure at the second attempt).
Measured: 1 month
Secondary outcomes (4)
Composite measure of Hemodynamic parameters , change 20% from baseline in Mean Blood Pressure and Heart Rate
Measured: baseline and 1 month
Number of Participants with oropharyngeal ( edema, haemorragie, blood in sputum) and systemic complications (anaflactic reactions)
Measured: 1 month
Time to successful insertion time and effective airway [ time to observation of 3 consequtive correct End-Tidal CO2 (EtCO2 )waves after insertion ] defined as insertion time and was recorded.
Measured: 1 monyh
Measure if the inserted device failed to provide adequate ventilation, the device position was changed within the oral cavity, which was then defined as repositioning
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Erdal Komur, MD, Principal investigator, Istanbul Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339519
- Sponsor's protocol ID
- GK4
- Status last verified
- Dec 2015
- First submitted
- 3 Jan 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Timmermann A, Cremer S, Heuer J, Braun U, Graf BM, Russo SG. [Laryngeal mask LMA Supreme. Application by medical personnel inexperienced in airway management]. Anaesthesist. 2008 Oct;57(10):970-5. doi: 10.1007/s00101-008-1425-8. German.
PubMed 18712321Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
PubMed 20540172
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Supraglottic Airway Devices; Lma Classic, Lma Fastrach and Lma Supreme; a Prospective, Randomized, Clinical Trial of Efficacy, Safety and Complications
- ClinicalTrials.gov ID
- NCT02339519
- Acronym / sponsor ID
- GK4
- Conditions
- Airway Management
- Keywords
- Laryngeal Masks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic complications.
Detailed description
As a result of studies regarding the provision of an airway which is less invasive than intubation but safer than mask to maintain patency of airway after anesthesia induction in brief surgical interventions, supraglottic airway devices have been introduced into practice. They are inserted to glottic entry via the oral route and can be used in emergent conditions where tracheal intubation and mask anesthesia are challenging.
Classic LMA was first introduced by Archie Brain, MD in 1988, and consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
Fastrach LMA ( LMA Fastrach: LMA North America. Inc. San Diego. CA) was first introduced in 1997 and has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
Supreme LMA, first introduced in April, 2007, is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner because of the advanced cuff and airway tube. The integrated gastric canal facilitates gastric aspiration.
Supraglottic airway devices seem to have advantages over each other in different aspects due to their distinct features. In literature, there are studies comparing various LMA types for different features. However, to best of our knowledge, there is no study comparing these 3 types of LMA regarding these parameter. This is the main point of difference of our study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group LMA supreme | Active comparator | Device: LMA SUPREMEPatients who received Laryngeal Mask Airway; LMA supreme |
| group LMA classic | Active comparator | Device: LMA CLASSICPatients who received Laryngeal Mask Airway; LMA classic |
| group Fastrach | Active comparator | Device: LMA FASTRACHPatients who received Laryngeal Mask Airway; LMA fastrach |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- normotensive patients with mouth aperture > 3 cm,
- thyromental distance > 6 cm,
- sternomental distance > 12.5 cm,
- body mass index < 35 kg m-2 were included in the study.
Key exclusion criteria (7 listed)
- patients with ASA III-IV,
- those with a history of gastroesophageal reflux,
- pregnancy,
- cardiovascular and central nerve system disease,
- those with difficulty in cooperation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA CLASSICClassic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask. | Device | group LMA classic |
| LMA FASTRACHFastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment. | Device | group Fastrach |
| LMA SUPREMESupreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner. | Device | group LMA supreme |
Primary outcome
Ease of insertion will be rated using a 4-point scale (4: success at the first attempt without tactile resistance; 3: success at the first attempt with tactile resistance; 2: success at the second attempt; 1: failure at the second attempt).
Time frame: 1 month
4 secondary outcomes
Composite measure of Hemodynamic parameters , change 20% from baseline in Mean Blood Pressure and Heart Rate
Time frame: baseline and 1 month
Number of Participants with oropharyngeal ( edema, haemorragie, blood in sputum) and systemic complications (anaflactic reactions)
Time frame: 1 month
Time to successful insertion time and effective airway [ time to observation of 3 consequtive correct End-Tidal CO2 (EtCO2 )waves after insertion ] defined as insertion time and was recorded.
Time frame: 1 monyh
Measure if the inserted device failed to provide adequate ventilation, the device position was changed within the oral cavity, which was then defined as repositioning
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Background: PubMed 18712321Timmermann A, Cremer S, Heuer J, Braun U, Graf BM, Russo SG. [Laryngeal mask LMA Supreme. Application by medical personnel inexperienced in airway management]. Anaesthesist. 2008 Oct;57(10):970-5. doi: 10.1007/s00101-008-1425-8. German.
- Background: PubMed 20540172Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdal Komur, MD principal investigator
Istanbul Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LMA CLASSIC, LMA FASTRACH and LMA SUPREME in people with Airway Management, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of insertion will be rated using a 4-point scale (4: success at the first attempt without tactile resistance; 3: success at the first attempt with tactile resistance; 2: success at the second attempt; 1: failure at the second attempt). (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339519, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.